Effect of Xalacom® (Latanoprost/Timolol) and Combigan® (Brimonidine/Timolol) Fixed Combination on Intraocular Pressure and Ocular Blood Flow in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00706927

Last Updated: 2014-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-09-30

Brief Summary

Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. The main focus of glaucoma is still directed towards a decrease in IOP. There is, however, also considerable interest whether antiglaucoma drugs influence ocular perfusion. Although measurement of ocular blood flow is still difficult, a number of innovative techniques have been realized which cover different aspects of ocular perfusion. In the present study Xalacom® (latanoprost/timolol) and the fixed combination of Combigan® (brimonidine/timolol) will be compared with respect to their IOP lowering efficacy as well as their ocular hemodynamic effects.

Conditions

Retina; Ocular Physiology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

latanoprost 0.005% + timolol 0,5% fixed combination

1 drop per day and eye for 6 weeks

Intervention Type: DRUG

brimonidine 0,2% + timolol 0,5% fixed combination

1 drop twice a day per eye for 6 weeks

Intervention Type: DRUG

Other Intervention Names

Xalacom® (latanoprost/timolol); Combigan® (brimonidine/timolol)

Eligibility Criteria

Inclusion Criteria

• Men and women over 18 years
• Unilateral or bilateral primary open angle glaucoma, ocular hypertension, exfoliation glaucoma, pigmentary glaucoma with IOP between 22 -35mmHg
• At least 3 reliable visual field testings
• 4 weeks for ß adrenergic receptor antagonists and prostaglandin analogues, 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors

Exclusion Criteria

• History of acute angle closure
• Closed or barely open anterior chamber angle
• Mean deviation of visual field testing > 10
• Intraocular surgery or argon laser trabeculoplasty within the last six months
• Ocular inflammation or infection within the last three months
• Contact lenses
• Patients with bradycardia (heart rate < 50 beats/min)
• Second and third degree heart block
• Asthma
• COPD
• Congestive heart failure
• Severe renal impairment (creatinine clearance < 1.8 L/h)
• History of hypersensitivity to one of the study drugs or drugs with similar chemical structure
• Topical or systematically/oral therapy with steroids
• History of non-IOP responder to beta-blockers, alpha-2 adrenergic or prostaglandin analogues
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Assoc. Prof. Priv. - Doz. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Wolzt, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

Department of Clinical Pharmacology

Vienna, , Austria

Countries

Austria

Other Identifiers

OPHT-241005

Identifier Type: -

Identifier Source: org_study_id